itraconazole
ITRACONAZOLE ORAL SOLUTION
Approved
Approval ID
8e41e42c-3ae0-4091-970b-bc0086755f1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Patriot Pharmaceuticals, LLC
DUNS: 178220385
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
itraconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10147-0150
Application NumberNDA020657
Product Classification
M
Marketing Category
C73594
G
Generic Name
itraconazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (10)
ADRABETADEXInactive
Quantity: 400 mg in 1 mL
Code: 8W6Q67R6NX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
ITRACONAZOLEActive
Quantity: 10 mg in 1 mL
Code: 304NUG5GF4
Classification: ACTIB